Automated System and Method for Harvesting or Implanting Follicular Units

ABSTRACT

Automated systems and methods for creating a plan for performing a procedure (for example, hair transplantation) are provided. In some embodiments, the plan is generated automatically by a processor. A user interface may be configured to allow a user to input one or more of the parameters of the plan. In certain embodiments, the hair transplantation plan takes into consideration existing hair.

RELATED APPLICATION DATA

The present application is a continuation of co-pending U.S. patentapplication Ser. No. 14/177,462, filed Feb. 11, 2014, which is acontinuation of U.S. patent application Ser. No. 13/112,171, entitled“Automated System for Harvesting or Implanting Follicular Units”, filedMay 20, 2011, now U.S. Pat. No. 8,690,894 issued Apr. 8, 2014, which isa continuation of U.S. patent application Ser. No. 11/380,907, entitled“Systems and Methods for Aligning a Tool with a Desired Location orObject”, filed Apr. 28, 2006, now U.S. Pat. No. 7,962,192 issued Jun.14, 2011, which claims the benefit under 35 U.S.C. §119 to U.S.provisional patent application Ser. No. 60/722,521, filed Sep. 30, 2005,60/753,602, filed Dec. 22, 2005, and 60/764,173, filed Jan. 31, 2006.The foregoing applications are all hereby incorporated by reference intothe present application in their entirety.

FIELD OF INVENTION

This invention relates generally to an image-guided robotics system forperforming precision diagnostic and therapeutic medical procedures.

BACKGROUND

U.S. Pat. No. 6,585,746 discloses a hair transplantation systemutilizing a robot, including a robotic arm and a hair follicleintroducer associated with the robotic arm. A video system is used toproduce a three-dimensional virtual image of the patient's scalp, whichis used to plan the scalp locations that are to receive hair graftsimplanted by the follicle introducer under the control of the roboticarm. The entire disclosure of U.S. Pat. No. 6,585,746 is incorporatedherein by reference.

SUMMARY

In accordance with a general aspect of the inventions disclosed herein,an automated system, such as an image-guided robotics system, isemployed for performing precisely controlled diagnostic and therapeuticmedical procedures, such as (by way of non-limiting examples) hairremoval and/or transplantation, repetitive needle injections (e.g., fordelivery of collagen fillers, melanocyte, tattoo ink), tattoo or moleremoval, application of laser or radio frequency (RF) energy, cryogenictherapy (e.g., for mole or wart removal), patterned micro-tissue removal(e.g., as an alternative to a conventional “face lift” procedure), andany other procedure currently performed using human-controlled devices.

According to according to some embodiments, an automated system may alsobe employed for performing diagnostic evaluations, such as, e.g.,obtaining precision image data for skin cancer screening, and performingultrasound diagnostics. In various embodiments, the robotics systemgenerally includes a robotic arm controlled by a system controller, anend-effecter assembly coupled to a distal (tool) end of the robotic arm,and an image acquisition system, including one or more high speedcameras coupled to the end-effecter assembly for acquiring images thatare processed for providing control signals for movement of the roboticarm using a “visual-servoing” process.

In accordance with some embodiments of the invention, an automatedsystem for harvesting or implanting follicular units is provided, thesystem including a moveable arm, a tool mounted on the moveable arm, oneor more cameras mounted on the moveable arm, a processor configured toreceive and process images acquired by the one or more cameras, and acontroller operatively associated with the processor and configured toposition the moveable arm based, at least in part, on processed imagesacquired by the one or more cameras, wherein the moveable arm ispositionable such that the tool may be positioned at a desiredorientation relative to an adjacent body surface.

By way of non-limiting example, the automated system may be a roboticsystem, wherein the moveable arm is a robotic arm, and wherein theprocessor and controller may be configured for positioning the tool byvisual servoing of the robotic arm. In some embodiments, a single cameramay be employed, wherein the processor is configured to register areference coordinate system of the camera with a tool frame referencecoordinate system of the robotic arm. For example, the processor mayregister the camera reference coordinate system with the tool framereference coordinate system based on images of a fixed calibrationtarget acquired as the robotic arm is moved along one or more axes ofthe tool frame reference coordinate system. By way of another example, apair of cameras may be mounted to the robotic arm, wherein the processoris configured to register respective reference coordinate systems of thecameras with each other and with a tool frame reference coordinatesystem of the robotic arm. Again, the processor may register therespective camera reference coordinate systems with the tool framereference coordinate system based on images of a fixed calibrationtarget acquired as the robotic arm is moved along one or more axes ofthe tool frame reference coordinate system. By way of yet anotherexample, the one or more cameras comprises respective first and secondpairs of cameras mounted to the robotic arm, the first pair focused toacquire images of a first field of view, and the second pair focused toacquire images of a second field of view substantially narrower than thefirst field of view. In this embodiment, the processor may be configuredto register respective reference coordinate systems of the first andsecond pairs of cameras with each other and with a tool frame referencecoordinate system of the robotic arm. Again, the processor may registerthe respective camera reference coordinate systems with the tool framereference coordinate system based on images of a fixed calibrationtarget acquired as the robotic arm is moved along one or more axes ofthe tool frame reference coordinate system.

In various embodiments, the tool comprises one or both of a follicularunit harvesting tool and a follicular unit implantation tool. In variousembodiments, the processor may be configured to identify approximatephysical boundaries of a follicular unit in an image acquired by the oneor more cameras. For example, the processor may be configured foridentifying approximate physical boundaries of a follicular unitcaptured in an acquired image, including a subcutaneous base regionembedded in the body surface and a distal tip region extending away fromthe body surface, wherein the images include subcutaneous images. In yetanother embodiment, an air jet is provided on the moveable arm fordirecting an air stream at the body surface. In yet another embodiment,a user interface is provided for a user to input instructions to one orboth of the processor and controller regarding one or more of alocation, position, orientation, and depth of a follicular unit to beimplanted.

In accordance with further embodiments, an automated system forharvesting or implanting follicular units includes a moveable arm, atool mounted on the moveable arm, a pair of cameras, a processorconfigured to receive and process images acquired by the cameras,wherein the processor is configured to register respective referencecoordinate systems of the cameras with each other, and a controlleroperatively associated with the processor and configured to position themoveable arm based, at least in part, on processed images acquired bythe cameras, wherein the moveable arm is positionable such that the toolmay be positioned at a desired orientation relative to an adjacent bodysurface. By way of non-limiting example, the automated system may be arobotic system, wherein the moveable arm is a robotic arm, and theprocessor is further configured to register the respective camerareference coordinate systems with a tool frame reference coordinatesystem of the robotic arm. In such embodiment, the processor andcontroller may be configured for positioning the tool by visual servoingof the robotic arm.

In accordance with yet further embodiments, an automated system forharvesting or implanting follicular units includes a moveable arm, atool mounted on the moveable arm, first and second pairs of camerasmounted to the moveable arm, the first pair focused to acquire images ofa first field of view, and the second pair focused to acquire images ofa second field substantially narrower than the first field of view, aprocessor configured to receive and process images acquired by therespective pairs of cameras, wherein the processor is configured toregister respective reference coordinate systems of the camera pairswith each other, and a controller operatively associated with theprocessor and configured to position the moveable arm based, at least inpart, on processed images acquired by the respective pairs of cameras,and wherein the moveable arm is positionable such that the tool may bepositioned at a desired orientation relative to an adjacent bodysurface. For example, the automated system may be a robotic system,wherein the moveable arm is a robotic arm, and the processor may befurther configured to register the respective camera referencecoordinate systems with a tool frame reference coordinate system of therobotic arm.

Other and further objects and advantages of the invention will becomeapparent from the following detailed description when read in view ofthe accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is illustrated by way of example and not limitation in thefigures of the accompanying drawings, in which like references indicatesimilar elements, and in which:

FIG. 1 is a photograph of an embodiment of an image-guided roboticssystem, including a robotic arm for positioning and orienting anend-effecter tool at targeted locations on the skin surface of apatient.

FIG. 2 is a photograph showing first and second stereo camera pairssecured to the robotic arm of FIG. 1, and used to capture image datafrom multiple fields-of-view for guiding movement of the robotic arm andan attached end-effecter tool assembly.

FIG. 3 is a close-up photograph of the system of FIG. 2, more clearlyshowing the end-effecter tool.

FIG. 4 is a flow diagram of a procedure for calibrating an optical axisand associated camera reference frame of a single camera with a toolframe established at the distal (working) end of the robotic arm towhich the camera is attached.

FIG. 5 is a flow diagram of an iterative procedure for aligning (bothposition and orientation) an elongate end-effecter tool used forharvesting and/or implanting hair follicles with a selected hairfollicular unit.

FIG. 6 depicts a camera image of hair follicular units in a region ofinterest on a human scalp.

FIG. 7 illustrates exemplary position and orientation, i.e. defined byx,y offsets and in-plane and out-of-plane angles, of a hair follicularunit relative to the camera reference frame.

FIG. 8 is a flow diagram of an automated procedure for identifying aposition and orientation of each of a multiplicity of follicular unitsin a region of interest on a human scalp, and then harvesting some orall of the identified follicular units.

FIG. 9 is a flow diagram of an algorithm that uses images acquired froma stereo pair of cameras for identifying follicular units in a region ofinterest, and then computes the respective locations and orientations ofthe identified follicular units.

FIG. 10 is a three-part tool for follicular unit harvesting, recipientsite incision, and graft placement, according to one embodiment of theinvention.

FIG. 11 is an end-effecter apparatus used for driving the respectivethree parts of the three-part tool of FIG. 10.

FIG. 12 is a photograph of a semi-circular cylinder used as a rotationalcutter for harvesting hair follicles, according to one embodiment of theinvention.

FIG. 13 is a flow diagram of an algorithm using control points to designa natural looking (implanted) hairline.

FIG. 14 is a flow diagram of an algorithm using control points toprovide natural-looking randomness to implanted hair graft locations.

FIG. 15 is a flow diagram illustrating an automatic guidance feature ofan image-guided robotics system.

FIG. 16 is a flow diagram of an algorithm using stereovision foraccurately controlling the depth of a hair follicle implant.

FIG. 17 is a flow diagram of a procedure for harvesting hair follicles.

FIG. 18 is a flow diagram of a procedure for implanting hair follicles.

FIG. 19 illustrates an end-effector tool having a positioning assemblyin accordance with some embodiments.

FIG. 20 illustrates a holding unit located within the positioningassembly of FIG. 19 in accordance with some embodiments.

FIG. 21A illustrates a needle assembly in accordance with someembodiments.

FIGS. 21B-21D illustrate variations of a distal end of the needleassembly of FIG. 21A in accordance with different embodiments.

FIG. 22 illustrates the needle assembly of FIG. 21A being engaged withthe holding unit of FIG. 20.

FIG. 23 illustrates a follicular unit being harvested by a coring needlein accordance with some embodiments.

FIGS. 24A-24D illustrates a process for implanting a follicular unit inaccordance with some embodiments.

FIG. 25 illustrates a force diagram representing a force experienced bya coring needle in accordance with some embodiments.

FIG. 26 illustrates a cartridge for holding a plurality of coringneedles in accordance with some embodiments.

FIG. 27 illustrates a puncture needle holder in accordance with someembodiments.

FIG. 28 illustrates a positioning assembly in accordance with otherembodiments.

FIGS. 29A-29D illustrate a process of harvesting and implanting afollicular unit using the positioning assembly of FIG. 28, the cartridgeof FIG. 26, and the puncture needle holder of FIG. 27 in accordance withsome embodiments.

FIG. 30 illustrates a skin tensioner that can be used with embodimentsdescribed herein.

FIG. 31 illustrates a needle assembly in accordance with still otherembodiments.

FIGS. 32A-32C illustrate an exemplary method of using the needleassembly of FIG. 31 in accordance with some embodiments.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIG. 1 depicts an image-guided robotics system 25, including aprogrammable robotic arm 27 of a type manufactured and distributed byAdept Technology, Inc. (www.adept.com). Another source of robotic armassemblies suitable for embodiments of the invention are manufacturedand distributed by Kuka Robot Group (www.kuka.com). The robotic arm 27provides precisely controlled movement of a distal end plate (not seenin FIG. 1) in six degrees of freedom (x, y, z, ω, ρ, r), as iswell-known in the art. Such movement of the distal plate is providedwith a high degree of repeatability and accuracy (e.g., to 20 microns)by respective motors and encoders located in respective arm joints 34 ofthe robotic arm 27.

A variety of different end-effecter tools and/or assemblies may beattached to the distal end plate on the robotic arm 27 for performingvarious procedures on a human or animal patient. By way of example, theend-effecter assembly 30 shown in FIGS. 1-3 is designed for theharvesting and implantation of hair follicles from/in a human scalp. Itwill be appreciated that embodiments of the invention will employ manydifferent types of end-effecter tools and assemblies for performingdiagnostic and therapeutic medical procedures that take advantage of theability of the robotic arm 27 to rapidly and precisely position therespective tool (e.g., needle) or assembly at desired locations at theskin surface of a patient. It will be appreciated that the end-effecterassemblies may themselves include moving, controllable parts. By way ofexample, one end-effecter assembly comprises a reciprocating needle usedfor delivering precisely targeted, repetitive injections through thedermis.

As described in greater detail herein, movement of the robotic arm 27 isgoverned by a system controller (not shown), in response to controlsignals derived from image data acquired by a pair of “stereo” cameras28 attached to the distal end of the robotic arm (proximate theend-effecter assembly 30). In alternate embodiments, only a singlecamera need be used for image acquisition. Also, as depicted in FIG. 2(and also as described in greater detail herein), multiple pairs ofstereo cameras 28A and 28B may be used in order to capture differing(i.e., broader and narrower) fields-of-view. In still furtherembodiments, a single camera may be used to capture a first (i.e.,broad) field-of-view, and a second camera may be used to capture asecond (i.e., narrow) field-of-view. Other camera configurations arealso possible.

Image data acquired by the camera(s) 28 is processed in a computer (notshown in FIG. 1) associated with the robotics system 25, which providescontrol signals to the system controller for directing movement of therobotic arm 27. In particular, images are acquired from each camera ofthe pair 28 at a desired magnification (e.g., in a range of 6× to 10× inone embodiment) and duty cycle (e.g., 30 hertz in one embodiment). Theacquired images are digitized using known image segmentation techniquesimplemented in software on the computer in order to identify theposition(s) and orientation(s) of objects of interest. In the case ofprocedures involving the removal or implantation of hair follicles, itmay be desirable to die the hair follicles of interest with a dark colorprior to a procedure, in order to increase the effectiveness of theimage processing techniques. It may also be desirable to cut the hairfollicles in the region(s) of interest to a substantially uniform lengthprior to the procedure.

As will be appreciated by those skilled in the art, one can visualizebelow the skin surface by adjusting the lighting, filters on thecameras, and various image processing techniques. This is because thereflection and absorption of light by the skin surface will change basedon the wavelength of light used. Further, the depth of penetration ofthe light itself into the skin also varies based on the wavelength.Understanding these basic properties of light, images of thesubcutaneous portions of the follicular units (hair follicles) may beobtained using appropriate respective wavelengths of light, includingboth visible light spectrum and infrared, capturing the differentwavelengths of light using different imaging filters, and subtractingand/or combining images during image processing. This approach enablesone to visualize the hair shaft of the follicular unit, both outside theskin, as well as under the skin surface, including all the way down tothe bulb.

More particularly, the robotics system 25 is able to precisely trackmovement of the distal end plate (and end-effecter tool or assembly) ineach of the six degrees of freedom (x, y, z, ω, ρ, r) relative to threedifferent reference frames. A “world frame” has its x,y,z coordinateorigin at a center point of the base 32 of the robotic arm 27, with thex-y coordinates extending along a plane in a surface of a table 36 onwhich the base 32 of the robotic arm 27 is attached. The z-axis of theworld frame extends orthogonally to the table surface through a firstsection of the robotic arm 27. A “tool frame” has its x,y,z coordinateorigin established at the distal end tool plate. Lastly, a “base frame”may be registered relative to the world and tool frames. Each cameraalso has a (two-dimensional) camera coordinate system (“camera frame”),in which the optical axis of the camera (“camera axis”) passes throughthe origin of the x,y coordinates. By aligning the respective worldframe, tool frame, base frame and camera frames, the system controllercan precisely position and orient an object secured to the tool plate(e.g., a needle) relative to another object, such as a hair follicularunit extending out of a patient's skin surface.

In order to physically align the camera axis with an axis of anend-effecter tool (e.g., an elongate needle cannula) fixed to the distaltool plate of the robotic arm 25, it is of practical importance to beable to calibrate, and thereby have the information to compensate for,the positional and rotational offsets between the end effecter “toolaxis” and the camera axis, as well as the deviation from parallel ofthese respective axes. An exemplary calibration procedure is illustratedin FIG. 4. As an initial matter, the proximal base of the robotic arm 27is mounted to the table surface 36, so that the table surface 36 isaligned with the x-y coordinate plane of the world frame of the roboticsystem. Thus, a point lying anywhere on the table surface has a x-ycoordinate location in the world frame, which can be identified in termsof x and y offset values (e.g., measured in mm) from the origin of theworld frame located at a center point of the robotic arm proximal baseinterface with the table surface 36, with the z coordinate location ofthe point in the world frame equal to zero.

At step 60, the camera axis of a single camera fixed to the distal endtool plate of the robot arm 27 is aligned with a fixed “calibrationpoint” located on the table surface 36. The base frame of the roboticsystem is then initiated, meaning that the origin of the base frame isset at the “calibration point” and the camera axis is aligned with thecalibration point on the table surface. This initial position is called“home” position and orientation, and the robot arm 27 always starts fromthis position, even in the absence of the calibration point.

At step 62, a scaling and orientation of the camera image relative tothe base frame is then determined by first moving the robotic arm 27(and, thus, the camera) a fixed distance (e.g., 5 mm) along the x axisof the base frame, so that the calibration point is still captured inthe resulting image, but is no longer aligned with the camera axis.Because the camera frame x-y axes are not aligned with the base framex-y axes, movement along the x axis of the base frame results inmovement in both the x and y directions in the camera frame, and the newlocation of the calibration point is measured in the camera frame as anumber of image pixels in each of the x and y directions between thepixel containing the relocated camera axis and the pixel containing thecalibration point.

This process is repeated by moving the robotic arm 27 (and camera) afixed distance (e.g., 5 mm) along the y axis of the base frame, andagain measuring the x,y offsets in the camera frame of the new locationof the calibration point. As will be appreciated by those skilled in theart, these measurements allow for scaling the physical movement of therobot/camera (in mm) to movement of an object in the camera image (inpixels), as well as the in-plane orientation of the x-y axes of thecamera frame relative to the x-y axes of the base frame. It will furtherbe appreciated that the scaling and orientation process of steps 60 and62 are repeated for each camera in a multiple camera system, wherebyvariances in image movement between respective cameras may also bedetermined and calibrated.

At step 64, once the camera frame is calibrated with respect to the baseframe, the camera axis is again aligned with a fixed calibration pointlying on the surface of table 36, wherein the base frame is returned tois “home” position and orientation (0,0,0,0,0,0). The robotic arm 27 isthen moved in one or more of the six degrees of freedom (x, y, z, ω, ρ,r), so that an end effecter tool (e.g., needle tip) attached to the toolplate contacts the calibration point. By precisely tracking the movementof the robotic arm 27 from the initial home position/orientation of thetool frame to its position/orientation when the tool tip is contactingthe calibration point, the system controller calculates thetranslational and rotational offsets between the initial home positionand the camera axis. Because the camera is fixed to the tool plate, themeasured offsets will be constant, and are used throughout the procedurefor alignment of the tool frame with the camera frame (and, byextension, the base frame).

As will be described in greater detail herein, when using a stereo pairof cameras, e.g., camera pair 28 in FIG. 1, the respective optical axes(and camera frames) of the cameras are typically not installed ormaintained in parallel, but are slightly verged, e.g., about 10 degrees,which may be compensated for through known image processing techniques.In particular, the respective camera frames are aligned to have a commonx (horizontal) axis, whereby a position and orientation (includingin-plane depth) of objects captured in the parallel images may bealigned using image-processing techniques. One advantage of using astereo camera pair 28 is that a “depth” in the camera frame of anidentified object may be calculated based on the differences of the x,yposition offsets of the object in the respective (left v. right) cameraframes. In particular, the depth of implantation of a hair follicularunit (“graft”) is important to the aesthetic result and is a challengeto achieve manually, particularly with the operator fatigue that resultswhen a large number of grafts are implanted. If the graft is implantedtoo deep, a divot-like appearance results; if implanted too shallow, abump results or the graft may not stay in position.

In order to calculate a depth of a selected object, such as a hairfollicular unit, the left and right images obtained from the stereocamera pair must first be aligned. Because the respective camera imagesare aligned horizontally, the same objects will appear in the samehorizontal scan lines of the two images. And, because the depth of anobject being imaged relative to the camera lenses is within a knownrange (e.g., established by the focal lengths of the respectivecameras), a selected object in a first image (e.g., a hair follicularunit) can be matched to itself in the second image (to thereby align theimages with each other) by calculating an effective depth of the objectwhen paired with the possible candidate objects in the second image(i.e., in the same scan line) to determine which “pair” has a calculateddepth in the possible range.

Another advantage of using a stereo camera pair 28 is the ability toobtain image data regarding the position and orientation of anend-effecter tool (e.g., a hair follicular unit harvesting tool 40 shownin FIGS. 2 and 3) in a same reference frame that image data is obtainedregarding the position and orientation of objects of interest (e.g.,hair follicles, wrinkle lines, tattoos, moles, etc.) on the skinsurface. The respective left and right camera frames are calibrated withthe tool frame in the same manner as described above for a single cameraframe. Once these offsets are established, the relative positions andorientations of the end-effecter tool and objects on the skin surface(e.g., hair follicular units) may be determined and tracked in the toolframe.

FIG. 5 is a simplified flow diagram of a procedure according to oneembodiment of the invention for aligning the position and orientation ofan elongate axis of the follicular unit harvesting tool 40 with anelongate shaft axis of a hair follicular unit extending from the scalp,using only a single camera for image acquisition. Briefly, theharvesting tool 40 generally comprises a hollow, tubular cannula havinga sharpened distal end for puncturing the epidermis and dermisimmediately around an outer circumference of a follicular unit in orderto envelop, capture and remove the entire follicular unit from the fattysubcutaneous tissues underlying the dermis, e.g., by rotating thecannula in a drill-like motion, or by a quick reciprocating thrust alongits longitudinal axis. The harvesting tool 40 may be advanced andwithdrawn by its own longitudinal motion (i.e., relative to the toolplate to which it is attached), or by longitudinal motion of the roboticarm 27, or by a combination of both, in order to core and remove therespective follicular units, e.g., by friction and/or with the aid of aweak vacuum. For example, the end-effecter may have its own controllerand actuation system that is separate from the robotics system 25.

A more detailed description of exemplary follicular harvesting tools andassemblies is provided below in conjunction with FIGS. 10-12. It shouldalso be appreciated that the positioning and orientation process usedfor aligning the elongate axis of the harvesting tool 40 with theelongate axis of a hair follicular unit will have much broaderapplicability than just for hair removal and/or implantation procedures.By way of non-limiting examples, substantially similar positioning andorientation procedures may be used for aligning a laser, or an injectionneedle, with desired physical features and/or locations on a patient'sskin surface in a timely and precise manner.

After the robotics system 25 has been initiated and calibrated so thatthe camera frame is aligned with the tool frame (described above inconjunction with FIG. 4), image data is acquired and processed by thesystem computer to identify objects of interest in the camera frame. Byway of example, FIG. 6 depicts, a camera image of hair follicular unitsin a region of interest 50 on a human scalp. From images of this regionof interest 50, image segmentation and screening software residing inthe computer identifies and selects one or more particular follicularunits of interest for harvesting from the scalp. With reference to FIG.7, a position of a selected hair follicular unit 52 is identified interms of its x,y offset coordinates in the camera frame (the z axisbeing the camera optical axis which is preferably aligned substantiallyorthogonal to the surface of the scalp at the region 50).

Unless the camera axis happens to be exactly aligned with thelongitudinal axis of the follicular unit 52 (in which case thefollicular unit will appear as a circular point representing an end viewof the hair shaft), the image of follicular unit will be in the form ofan elongate line having an “apparent” length that will depend on theangle of the camera frame relative to the follicular unit. Because ofphysical attributes of a hair follicular unit, its base (i.e., the endemerging from the dermis) can be readily distinguished from its tip aspart of the image segmentation process. For example, the base portionhas a different profile and is generally thicker than the distal tipportion. Also, a shadow of the follicular unit can typically beidentified which, by definition, is “attached” at the base.

The x,y locations of the follicular unit base in the camera frame arethen calculated and represent the position offsets of the hair base.Orientation offsets of the follicular unit 52 are also calculated interms of (i) an in-plane angle α formed by the identified follicularunit shaft relative to, and in the same plane as, the x (or y) axis ofthe camera frame; and (ii) an out-of-plane angle δ that is an “apparent”angle formed between the follicular unit shaft and the scalp, i.e.,between the follicular unit and the plane of the x,y axes of the cameraframe. As noted above, the hair shaft is preferably trimmed prior to theprocedure to a substantially known length, e.g., 2 mm, so theout-of-plane angle δ may be calculated based on a ratio of a measuredapparent length of the image of the follicular unit to its presumedactual length, which ratio is equal to the cosine of the out-of-planeangle δ.

Returning to FIG. 5, at step 42, the x,y position and orientationoffsets are identified for a selected hair follicular unit, as describedabove. The computer then calculates the necessary movements of therobotic arm 27 to cause the camera axis to be aligned in the sameposition and orientation of the calculated offsets. The base frame andtool frame are also “moved” by the same x,y and rotational offsets(i.e., until angles α and δ are both equal to 0), so that the camera,base and tool frames remain aligned at the new position and orientationof the camera axis. Because of the inherent possible variances anderrors in the system and in the assumptions (e.g., regarding the hairfollicular unit length) the actual position and orientation of the hairfollicular unit may not match the calculated values. Thus, once therobotic arm 27 (and camera axis) is moved by the calculated positionaland rotational offsets, the follicular unit is again imaged and (at step46) a determination is made as to whether the camera axis is alignedwith the position and orientation of the follicular unit withinacceptable tolerances. If the camera axis is adequately aligned with thefollicular unit, the robotic arm 27 is moved a last time (at step 48) inorder to align the harvesting tool 40 in the “confirmed” position of thecamera axis (i.e., based on the offsets obtained in the above-describedcalibration process). However, if the (in step 46) the camera axis isnot adequately aligned with the hair follicular unit, the procedures insteps 42-46 are repeated, starting from the new camera axis location.

As will be appreciated by those skilled in the art, in embodiments ofthe invention, the duty cycle of the image acquisition and processing issubstantially faster than the movement of the robotic arm 27, and theprocess of identifying and calculating position and orientation offsetsof selected hair follicular units relative to the camera axis caneffectively be done “on-the-fly,” as the robotic arm is moving. Thus,the end destination (i.e., position and orientation) of the robotic arm27 (and harvesting tool 40) may (optionally) be constantly adjusted(i.e., fine tuned) as the harvesting tool 40 is moved into alignmentwith the follicular unit. Because such adjustments begin immediately,movement of the robotic arm 27 is more fluid and less jerky. Thisiterative feedback process, referred to as “visual-servoing,”continually calculates and refines the desired position and orientationof the harvesting tool 40, in order to minimize the image of the hairfollicular unit, i.e., until the image transforms from a line to apoint.

Thus, in embodiments of the invention, the image-guided robotics system25 may be used to perform automated or semi-automated procedures foridentifying position and orientation of a large number of hairfollicular units in a region of interest on a patients scalp, and thenaccurately harvest some or all of the follicular units. One or morecameras attached to the working distal end of the robotic arm captureimages at a desired magnification of a selected area of the patient'sscalp. A computer system processes the images and identifies (throughknown thresholding and segmentation techniques) the individual hairfollicular units, as well as their respective positions and orientationsrelative to the camera frame. Through a user-interface (e.g., a displayand a standard computer mouse), an attending surgeon may define a regionon the scalp from which hair follicular units are to be harvested anddefines a harvesting pattern, such as, e.g., taking every other hairfollicular unit in the region, leaving a defined number of follicularunits between harvested follicular units, taking a certain percentage offollicular units, leaving behind an aesthetically acceptable pattern,etc.

For example, images obtained from a wide field-of-view pair of stereocameras may be used by the attending physician to locate generally aregion of interest, while images obtained from a narrow field-of-viewpair of stereo cameras are used to accurately guide the harvesting toolwith the individual selected follicular units. Once the hair follicularunits to be harvested have been identified, the robotics systemsystematically aligns a harvesting tool (e.g., harvesting tool 40) witheach hair to be harvested; the respective hair follicles are harvested,and the process is repeated for all of the selected follicular units inthe defined harvest region. It will be appreciated that in some cases,the individual hair follicular units being harvested are then implantedin another portion of the patient's scalp, whereas in other instancesthe harvested hair follicular units are discarded. It will also beappreciated that, rather than a coring harvesting tool, such as tool 40,another type of hair removal end-effecter tool may be employed, such as,e.g., a laser. It will be still further appreciated that theabove-described techniques for aligning the camera frame with the robottool frame for precisely aligning an end-effecter tool may be equallyapplicable to other types of end-effecter tools, such as an injectionneedle (or a plurality of injection needles) used for injecting ink forforming tattoos on a skin surface of a patient.

FIG. 8 is a flow diagram of an automated (or semi-automated) procedurefor identifying a position and orientation of all follicular units in aregion of interest on a patient's scalp, and then accurately harvestingsome or all of the identified follicular units.

FIG. 9 is a flow diagram of a procedure using a stereo pair of camerasto identify individual follicular units in a region of interest on apatient's scalp, and then compute a location and orientation of each inthe respective camera frames and robot tool frame. The procedure startsby calibrating the stereo pair of cameras to identify both intrinsic andextrinsic parameters, in accordance with well known techniques.Intrinsic parameters are intrinsic to the individual camera, such asinternal optics, distortion, scaling, and the like. Extrinsic parametersrelate to characteristics between the two cameras, e.g., differences inthe alignment of their respective optical axes (which are ideallyparallel to one another, but as since this is unlikely as a practicalmatter, mathematical compensation is required). Calibration of intrinsicand extrinsic parameters are known in the field of stereo imaging andwill not be explained in detail herein. As discussed above, thelocations of the centers of the hair follicles are identified andmatched in both the left and right rectified images. The head and tailof each hair follicle is then identified in both the left and rightimages, wherein the three dimensional coordinates of the head and tailof the hair follicle may be calculated. Finally, the relative offset ofthe location and orientation of the hair follicle and the cannula aredetermined by employing the images of the cameras which see both thecannula and the hair follicle, in accordance with well known stereoimaging techniques.

The aesthetic result of a hair transplant procedure depends in part onimplanting the grafts in natural-looking patterns. The computer canefficiently “amplify” the surgeon's skill by “filling in the blanks”among a small fraction of the implant sites for which the surgeondetermines graft location and orientation. Achieving a natural-lookinghairline is particularly important for a good aesthetic result. Insteadof painstakingly making incisions for all of the near-hairline implantsites, the surgeon indicates a few hairline implant locations andorientations and the computer fills in the rest by interpolating amongthe designated sites, using the imaging system to identify and avoidexisting follicular units.

FIG. 13 illustrates an algorithm using control points to design naturallooking hairline. A curve is designed using control points based on, forexample, b-spline cubic polynomials. The control points are specified bythe operator. The orientation of the hair at each of the control pointsis specified. Points along the curve are identified at a given spacing,for instance, by interpolation. The locations of the points along thecurve may be randomized to make a natural looking hair line. The amountof randomization may be user-specified or computer-generated. It ispreferable that the follicular unit orientations are not randomized butare interpolated, for example, the same way a cubic spline is generated.Randomization of the location and interpolation of the orientationcreate more natural looking implants.

Natural looking randomness is important in both the critical hairlineregion and in the balance of the recipient sites. This can be achievedusing the procedure illustrated in FIG. 14, wherein a surface isdesigned using control points based on, for example, b-spline cubicsurfaces. Again, the orientation of the hair at each of the controlpoints is specified Implant points along the surface are identified at agiven spacing. The locations of the points along the surface may berandomized to make a natural looking hair distribution. The amount ofrandomization may be user-specified or computer-generated. Again, theorientation of the respective follicular units is preferably notrandomized, but interpolated the same way a cubic spline surface isgenerated. Randomization and interpolation schemes are known in the art,and can be adapted for this method.

It is often desirable to leave the existing hair in the recipient regionat its natural length, which can interfere with the vision system'saccess to individual recipient sites. This can be overcome by a gentleair jet directed at the recipient site, causing the hair in that regionto be directed away from the target site. If necessary, the hair can bedampened to facilitate this step. The air jet also can disperse bloodthat emerges from the incised recipient site, thus maintaining visualaccess during graft implantation. Such an air jet can be part of a morecomplex end-effecter assembly attached to the robotic arm tool plate,and which may also include one or more hair follicle harvesting and/orimplantation needles.

The robotics system 25 uses real-time information from the vision systemto monitor the position of the patient (typically using fiducial markersin the recipient region of the scalp), of the implanting tool, and ofexisting follicular units to guide the implanting tool into place forincising the recipient site and implanting the graft. FIG. 15 shows anexample of the automatic guidance feature of the robotic system,including the step of planning implant locations and orientations withrespect to global landmarks (e.g., existing hairs, tattoos, or otherdistinguishing features). The robot is then moved to register landmarkson the patient. The register information can be stored in memory forreference. The robot can make use of the registered landmarks asreference points for recognizing its position relative to the workingsurface. The robot is moved to each of the implant location andorientation with respect to the global landmarks. The global landmarksprovide a global reference for global movements. The location andorientation are fine-tuned based on the nearby landmarks such asneighboring preexisting hairs or newly implanted hairs. The nearbylandmarks provide a local reference for local movements.

Hair transplantation generally includes three steps: follicular unitharvesting, recipient site incision, and graft placement. The efficiencyof the surgery can be enhanced if these functions are accomplished witha single tool. FIG. 10 shows an embodiment of a three-part tool foraccomplishing the three functions. The three coaxial elements are anouter cannula (“puncture needle”) with a sharp bevel cut that is usedfor making the recipient-site incision, a second cannula (“coringneedle”), that slides inside the outer needle and is used for cuttingaround the donor graft, and an obturator that slides inside the secondcannula and is used for positioning the graft at the appropriate depthin the recipient site. For harvesting, the second cannula cuts thetissue (by rotating or by a quick thrust) while being advanced to thedesired depth for separating the follicular unit from the skin down tothe level of fatty tissue. The graft is then captured within thiscannula by advancing the cannula into the fatty tissue surrounding thefollicular unit bulb without a cutting motion. The cannula then extractsthe graft using friction between the graft and the inside of the cannulaor a combination of such friction and vacuum. For recipient siteincision, the outer cannula is advanced beyond the harvesting cannulaand is use to make an incision at the desired location with the desiredorientation and depth. The obturator then holds the graft at the desireddepth while the two cannulae are retracted.

In the three-part tool of FIG. 10, it is necessary to move each of thethree elements independently of the other two. And, if the harvestingcannula cuts by rotation rather than a linear quick thrust, there is amechanism for rotating that cannula. FIG. 11 shows an embodiment of anapparatus for producing the required motions of the tool elements,including rotation and advancement of the harvesting cannula,advancement and retraction of the implant cannula, and advancement andretraction of the obturator. A translation mechanism or linear motorprovides advancement and retraction of the implant cannula. A rotationand advancement motor or mechanism provides both translational androtational movement of the harvesting cannula. Another translationmechanism or linear motor provides advancement and retraction of theobturator. The mechanisms and motors typically employ a combination ofmotors, cams, and springs, but any suitable mechanism can be used toprovide translational and rotational movement of the tool parts.

FIG. 17 depicts a general sequence of actions for harvesting hairfollicles using a system according to embodiments of the invention,Initially, the robot is moved so that the harvesting needle is alignedwith the hair follicle, both in location and orientation. The harvestingneedle is then advanced so that the needle cannulates the hair follicle.The needle is advanced into the patient to cut the skin at apredetermined speed in step (e.g., to produce a quick jab or thrust).The needle is advanced into the patient's scalp to cut through the fattylayer underneath the skin. The needle is retrieved out of the patientand stops turning. Sometimes, the hair follicle will be lifted by theharvesting needle, as the harvesting needle is retrieved. Alternatively,an extraction mechanism, such as a vacuum, can be provided to extract orharvest the hair follicle. The vacuum is coupled via a suction tube tothe harvesting needle to provide suction to harvest the hair follicle.

FIG. 18 depicts a general sequence of actions for implanting hairfollicles using a system according to embodiments of the invention.Initially, the robot is moved so that the three part tool is alignedwith the implant location and orientation. The implant needle is thenadvanced so that it is in front of the harvesting needle. The needleassembly or tool is advanced so that the implant needle parts the skinat the implant location. The obturator is then advanced to push thegraft into the precise depth in the parted skin. Holding the obturatorin place, the implant needle is then retracted out of the patient. Theobturator is then retrieved to its standby position. FIG. 16 is a flowdiagram of a sequence of actions for accurately controlling the depth ofthe implant.

Another feature of the invention relates to the automatic loading andunloading of multiple needles and multiple-needle cassettes. In thetypical procedure, the patient is prone or semi-prone during theharvesting of grafts from a donor region in the back of the head and issitting erect during implantation of grafts in a recipient region at thefront hairline or top of the head. While it is possible to harvest asingle follicular unit from the donor site and then implant itimmediately in the recipient site by suitably moving the robotic armand/or the patient, it is faster to keep the patient in the prone ornear-prone position while harvesting a number of grafts (hundreds, atleast), then move the patient to the upright position for implanting allthose grafts. This can be accomplished using cassettes that hold anumber of tools, typically in the range of fifty to one hundred. Thecassettes may be in the form of revolving cylinders with multiplechambers, one for each tool, or may have a rectilinear array ofchambers. The individual tools are indexed into place for use inharvesting and implanting. Multiple cassettes may be sequentially loadedonto the robotic arm (an operation that can be either manual orautomated using standard robot-loading procedures) to harvest andimplant large numbers of grafts without changing the patient's position;for example, ten cassettes of one hundred chambers each would be usedfor one thousand grafts. It is possible to have just harvesting cannulaein the cassettes, using a single implanting cannula and obturator for anumber of harvesting cannulae by appropriately indexing the cassettesduring the implanting stage of the transplant procedure.

For example, a cassette may have a plurality of chambers, and multiplecassettes can be provided in the robotic arm. While a circularcylindrical cylinder with a sharp cutting edge (which may be serrated tofacilitate cutting) is an obvious configuration because of itssimilarity to dermatological biopsy punches, other shapes also work. Forexample, a semi-circular cylinder (as shown in FIG. 12) is an effectiverotational cutter. If it is close to 360 degrees, it can capture thegraft for extraction. If it is significantly less than 360 degrees, anadditional cannula (which may be the implanting cannula) will beadvanced to capture the graft. Similarly, an array of pins can be usedfor rotational cutting. Furthermore, shapes other than circular orsemi-circular can be used for quick-thrust cutting.

In accordance with another aspect of the inventions disclosed herein,the robotic system 25 may be employed to perform procedures that involvethe patterned removal of tissue. In particular, persons seek a “facelift” procedure because their skin has lost its elasticity and texture,and has stretched out. The surgeon's objective in performing a face liftis to restore texture and consistency, and to remove excess tissue. Anundesirable side effect is that, when the surgeon pulls the tissue totighten it, an unnatural rearrangement of anatomical features canresult. For example, one well known technique is for the surgeon toremove an entire section of scalp, and pull the remaining scalp togetherto tighten the tissue. As an alternative to such wholesale tissueremoval, it may be desirable to perform multiple (e.g., hundreds, eventhousands) of “punch-biopsy” type micro-tissue removals in apredetermined pattern across a patient's scalp using an appropriatelysized coring needle, and depend on the skin's natural ability to healthe micro-incisions, as it does following a hair transplantationprocedure. An appropriate end-effecter needle would be used similar tothe one used for harvesting hair follicles, but with a smaller coringdiameter. Rather than targeting hair follicles, the same imageprocessing techniques described above can be used to avoid harm toexisting hair follicles, while removing bits of tissue throughout atargeted region of the scalp. By employing a relatively small needle,the wound healing process can occur without a resulting scar from anincision, and without the unnatural realignment of anatomical features.Use of the robotically controlled system for needle location, alignmentand depth control allows for such a procedure within a relativelyreasonable amount of time, and without the necessary complications andrisks due to physician fatigue caused by repetitive manual tissuepunches.

In accordance with yet another aspect of the inventions disclosedherein, the above-described image processing techniques and embodimentsmay be employed for diagnostic procedures with or without the roboticsystem. For example, the robotic arm 27 may be used to maneuver one ormore cameras 28 fixed to the distal tool plate, but without any furtherend-effecter assembly. In the alternative, the one or more cameras maybe mounted to a non robotic assembly, whether positionable or rigid, andwhether stationary or movable. Or the one or more cameras may be handheld. By way of non-limiting examples, such procedures may include: (i)examination of a patient's skin surface, or below the skin surface; (ii)detection and/or monitoring and/or tracking changes in skin conditionsover time; and (iii) for image data acquisition for supporting medicaltherapies such as the use of lasers, drug delivery devices, etc. Imagedata acquired by the imaging system can be stored as part of a patient'smedical history. Also, image data acquired by the imaging system can bestored, later processed, and/or enhanced for use in a telemedicinesystem.

FIG. 19 illustrates a distal portion of the robotics system 25 inaccordance with some embodiments. The robotics system 25 includes aforce sensor 100 secured to an arm 104, a plate 102 mounted to the forcesensor 100, and a positioning assembly 106 secured to the plate 102.Alternatively, the plate 102 could be secured directly to the arm 104,in which cases, the force sensor 100 may be secured between thepositioning assembly 106 and the plate 102. In further embodiments, theforce sensor 100 may be located within the positioning assembly 106.

The force sensor 100 is configured to sense three forces Fx, Fy, Fz inthree different orthogonal directions X, Y, Z, and three orthorgonalmoments Mx, My, Mz. In other embodiments, the force sensor 100 may beconfigured to sense one or two of the forces Fx, Fy, Fz, and/or one ortwo of the moments Mx, My, Mz. As shown in the figure, the force sensor100 is coupled to a computer 120, which receives data from the forcesensor 100 representing the sensed force(s) and/or moment(s). In otherembodiments, the force sensor data may go directly to the robot.

In the illustrated embodiments, the positioning assembly 106 includes aholding unit 109 for engagement with a needle assembly 110, and aplurality of positioners 107 a-107 c. The holding unit 109 is configuredto engage with different parts of the needle assembly 110 so that theneedle assembly 110, as a whole, can be positioned by the positioningassembly 106. The holding unit 109 also allows different components ofthe needle assembly 110 to be controlled after the needle assembly 110is engaged with the holding unit 109. The positioners 107 a-107 c areconfigured for moving different components of the needle assembly 110after it has been engaged with the holding unit. Although threepositioners 107 a-107 c are shown, in other embodiments, the positioningassembly 106 may include more or less than three positioners 107. Insome embodiments, the positioning assembly 106 includes the device ofFIG. 11, which includes three motors (positioners) for moving differentcomponents of the needle assembly 110.

FIG. 20 illustrates the holding unit 109 in accordance with someembodiments. The holding unit 109 includes a first engagement portion122 for engaging a first portion of the needle assembly 110, a secondengagement portion 124 for engaging a second portion of the needleassembly 110, and a third engagement portion 126 for engaging a thirdportion of the needle assembly 110.

FIG. 21A illustrates the needle assembly 110 in accordance with someembodiments. The needle assembly 110 has a similar configuration as thatshown in FIG. 10. The needle assembly 110 includes a coring needle 200,a puncture needle 202, and a plunger (obturator) 204. The coring needle200 has a proximal end 212, a distal end 214, a body 215 extendingbetween the proximal and distal ends 212, 214, and a lumen 217 definedat least partially by the body 215. In the illustrated embodiments, thelumen 217 has a cross sectional dimension that is between 0.5 millimeterand 1.5 millimeters, and more preferably, approximately 1 millimeter.The needle assembly 110 further includes a shaft 216 having a proximalend 218, a distal end 220, and a lumen 222 extending between theproximal and distal ends 218, 220. The proximal end 212 of the coringneedle 200 is secured to the distal end 220 of the shaft 216. Thepuncture needle 202 has a proximal end 232, a distal end 234, a body 230extending between the proximal and distal ends 232, 234, and a lumen 236within the body 230. The lumen 236 has a cross sectional dimension sizedfor accommodating at least a portion of the coring needle 200, and forallowing the coring needle 200 to slide relative to the puncture needle202. The distal end 234 of the puncture needle 202 has a sharp tip 250for piercing tissue.

In the illustrated embodiments, the distal end 214 of the coring needle200 has a tubular configuration (FIG. 21B). In such cases, the edge 252of the coring needle 200 may have a sharp configuration for allowing thecoring needle 200 to penetrate tissue. In other embodiments, the distalend 214 of the coring needle 200 may have an arc configuration (FIG.21C). In such cases, the ends 254 of the arc portion may have a sharpconfiguration for allowing the coring needle 200 to cut tissue as thecoring needle 200 is rotated about its axis. In further embodiments, thedistal end 214 of the coring needle 200 can include a plurality ofcutting portions 256, with each cutting portion 256 having a sharp edge258 for cutting tissue (FIG. 21D). It should be noted that the distalend 214 of the coring needle 200 is not limited to the examplesdescribed previously, and that the distal end 214 can have otherconfigurations in other embodiments, as long as it can core tissue.

The needle assembly 110 further includes a first engagement portion 238and a second engagement portion 240. The first engagement portion 238has a tubular configuration, and is secured to the shaft 216. The secondengagement portion also has a tubular configuration, and is secured tothe proximal end 232 of the puncture needle 202. proximal end 232 of thepuncture needle 202. The first and the second engagement portions 238,240 are sized and shaped to engage with corresponding components of theholding unit 109. It should be noted that the first and secondengagement portions 238, 240 are not limited to the example of theconfiguration illustrated, and that the engagement portions 238, 240 canhave other configurations in other embodiments. For example, inalternative embodiments, the engagement portion 238 does not have atubular configuration. In such cases, the engagement portion 238 can bea structure that is secured to, or extends from, a surface of the shaft216. Similarly, in other embodiments, the engagement portion 240 can bea structure that is secured to, or extends from, a surface of thepuncture needle 202, and needs not have a tubular configuration. Asshown in the figure, the needle assembly 110 also includes a connector248 secured to the shaft 216. The connector 248 has a shape thatresembles a sphere, but may have other shapes in other embodiments.

The plunger 204 has a proximal end 242 and a distal end 244. The plunger204 is at least partially located within the lumen 217 of the coringneedle 200, and is slidable relative to the coring needle 200. Theneedle assembly 110 further includes a spring 246 coupled to the plunger204 for biasing the plunger 204 in a proximal direction relative to thecoring needle 200. In the illustrated embodiments, the plunger 204 isdescribed as a component of the needle assembly 110. In otherembodiments, the plunger 204 is not a part of the needle assembly 110.For example, the plunger 204 may be a component of the positioningassembly 106.

FIG. 22 illustrates the needle assembly 110 that has been engaged withthe positioning assembly 106. When the needle assembly 110 is snappedonto the positioning assembly 106, the first engagement portion 122 ofthe holding unit 109 is engaged with the connector 248, the secondengagement portion 124 is engaged with the first engagement portion 238of the needle assembly 110, and the third engagement portion 126 isengaged with the second engagement portion 240 of the needle assembly.The connector 248 allows the needle assembly 110 to be detachablysecured to the positioning assembly 106. The first engagement portion122 of the holding unit 109 is coupled to the first positioner 107 a. Insome embodiments, the coring needle 200 is not translatable. Inalternative embodiments, the first positioner 107 a is configured totranslate (e.g., advance or retract) the coring needle 200. The secondengagement portion 124 of the holding unit 109 is coupled to the secondpositioner 107 b, which is configured to rotate the coring needle 200about its axis. The third engagement portion 126 of the holding unit 109is coupled to the third positioner 107 c, which is configured totranslate (e.g., advance or retract) the puncture needle 202. In otherembodiments, the second engagement portion 124 of the holding unit 109may be coupled to both the first positioner 107 a and the secondpositioner 107 b. In such cases, the first positioner 107 a isconfigured to translate the engagement portion 124 to thereby advance orretract the coring needle 200, and the second positioner 107 b isconfigured to rotate the engagement portion 124 to thereby turn thecoring needle 200 about its axis. In further embodiments, the secondpositioner 107 b is not needed, and the needle assembly 110 does notinclude the engagement portion 238. In such cases, the positioningassembly 106 is not configured to rotate the coring needle 200, but toadvance and retract the coring needle 200 in a back and forth trustingmotion. In still further embodiments, the third positioner 107 c is notneeded, and the third engagement portion 126 is fixedly secured to theholding unit 109. In such cases, the puncture needle 202 may bepositioned by the robotic arm 27, and the coring needle 200 may bepositioned relative to the puncture needle 202 using the firstpositioner 107 a.

When using the needle assembly 110 to harvest a follicular unit, theneedle assembly 110 is first coupled to the positioning assembly 106.Such may be accomplished manually by snapping the needle assembly 110onto the positioning assembly 106. Alternatively, the needle assembly110 may be held upright by a stand (not shown). In such cases, therobotic arm 27 may be used to move the positioning assembly 106 to“grab” the needle assembly 110 from the stand. The camera(s) 28 may beused to provide information regarding a position of the needle assembly110 to the processor 120, which controls the robotic arm 27 based on theinformation, thereby placing the positioning assembly in engagementposition relative to the needle assembly 110.

Next, a treatment plan is inputted into the computer 120. In someembodiments, the treatment plan is a prescribed plan designed totransplant hair follicles from a first region (harvest region) to atarget region (implant region). In such cases, the treatment plan mayinclude one or more parameters, such as a number of hair follicles to beremoved/implanted, location of harvest region, location of implantregion, a degree of randomness associated with targeted implantlocations, spacing between adjacent targeted implant locations, depth offollicle, depth of implant, patient identification, geometric profile ofharvest region, geometric profile of implant region, marker location(s),and density of targeted implant locations. Various techniques may beused to input the treatment plan into the computer 120. In theillustrated embodiments, the treatment plan may be inputted using a userinterface that includes a monitor 122 and a keyboard 124. Alternatively,the treatment plan may be inputted using a storage device, such as adiskette or a compact disk. In other embodiments, the treatment plan maybe downloaded from a remote server. In further embodiments, thetreatment plan may be inputted using a combination of the abovetechniques. For example, some parameters may be inputted into thecomputer 120 using a diskette, while other parameters may be inputtedusing the user interface. In some embodiments, one or more parameters ofthe treatment plan may be determined in real time (e.g., during atreatment session).

After the treatment plan has been inputted into the computer 120, thecomputer 120 then registers the treatment plan with a patient. In someembodiments, such may be accomplished by using the camera(s) 28 toidentify one or more markers on the patient. The marker may be areflector that is secured to the patient, an ink mark drawn on thepatient, or an anatomy of the patient. The identified marker(s) may beused to determine a position and/or orientation of a target region onthe patient.

In the illustrated embodiments, the treatment plan includes a positionof the harvest region. Using input from the camera(s) 28, the computer120 identifies the location of the harvest region on the patient, and atarget follicular unit in the harvest region. The computer 120 thenoperates the robotic arm 27 to place the distal end 214 of the coringneedle 200 next to the target follicular unit. In some embodiments, thecoring needle 200 is positioned coaxial to the target follicular unit.Next, the coring needle 200 is used to harvest the target follicularunit 302 (FIG. 23). In some embodiments, such may be accomplished byactivating a positioner within the positioning assembly 106 to rotatethe coring needle 200. As the coring needle 200 is rotated, the coringneedle 200 may be advanced distally (e.g., by activating anotherpositioner within the positioning assembly 106, or by moving thepositioning assembly 106 using the robotic arm 27). In otherembodiments, the harvesting of the target follicle 302 unit may beaccomplished by thrusting the coring needle 200 forward and backward.While the coring needle 200 is used to core out the follicular unit 302,the puncture needle 202 is located proximally away from the distal end214 of the coring needle 200 to thereby prevent interference with thecoring procedure. Such may be accomplished by advancing the coringneedle 200 distally relative to the puncture needle 202, oralternatively, by retracting the puncture needle 202 proximally relativeto the coring needle 200 (if the puncture needle 202 can be positioned).

When the distal end 214 of the coring needle 200 has been advancedwithin a prescribed depth 300, e.g., 5 millimeter, below a skin surface306 (FIG. 23), the coring needle 200 is then retracted proximally toremove the coring needle 200 from the patient. In the illustratedembodiments, the camera(s) 28 may be used to monitor the coring processto thereby determine an amount of coring needle 200 that has beenadvanced below the skin surface 306. In some embodiments, the exteriorof the coring needle 200 may include marker lines to thereby allow thecamera(s) 28 or a physician to “see” how much of the coring needle 200has been advanced into the patient. In some embodiments, surfacefriction at the interface between the follicular unit 302 and theinterior surface 304 within the lumen 217 will hold the follicular unit302 as the coring needle 200 is removed from the patient, therebyharvesting the follicular unit 302. In other embodiments, the interiorsurface 304 can be texturized (e.g., having one or more indents orprotrusions) to thereby allow the distal end 214 to more easily holdonto the follicular unit 302 as the coring needle 200 is removed fromthe patient. In further embodiments, a proximal end of the needleassembly 110 may be coupled to a vacuum unit (not shown) located withinthe positioning assembly 106. In such cases, the vacuum unit createssuction within the lumen 217 of the coring needle 200, to thereby pullthe target follicular unit 302 away from its underlying tissue as thecoring needle 200 is removed from the patient.

After the follicular unit 302 has been harvested, the positioningassembly 106 then retracts the coring needle 200 proximally until thedistal end 214 is proximal to the distal end 234 of the puncture needle202. Alternatively, if the puncture needle 202 is positionable, thepuncture needle 202 may be advanced distally until the distal end 234 isdistal to the distal end 214 of the coring needle 200. Next, thecomputer 120 operates the robotic arm 27 to place the distal end 234 ofthe puncture needle 202 adjacent to a target location within an implantregion of the patient as prescribed by the treatment plan. The punctureneedle 202 is then advanced (e.g., by activating a positioner within thepositioning assembly 106, or by moving the positioning assembly 106distally towards the target location) to pierce through the skin 310 atthe implant region (FIG. 24A). The puncture needle 202 is advanced untilthe penetrated depth 312 is at least equal to the coring depth 300. Insome embodiments, the camera(s) 28 and the computer 120 may be used todetermine an amount of the puncture needle 202 that has been advancedinto the patient. For example, the puncture needle 202 may include aplurality of marker lines for allowing the camera(s) 28 or a physicianto “see” how much of the puncture needle 202 has been inserted into thepatient. As shown in the figure, the puncture needle 202 creates anopening 314 below the patient's skin 314, in which the follicular unit302 may be placed.

Next, the coring needle 200, which contains the harvested follicularunit 302, is advanced within the lumen 236 of the puncture needle 202,until a top surface 320 of the follicular unit 302 is at or below theskin 310 at the implant region (FIG. 24B).

Next, the plunger 204 may be advanced distally (e.g., by using anotherpositioner within the positioning assembly 106) until its distal end 244engages with the follicular unit 302 located within the coring needle200 (FIG. 24C). The puncture needle 202 and the coring needle 200 arethen retracted proximally relative to the plunger 204, thereby leavingthe follicular unit 302 implanted at the target location in the implantregion (FIG. 24D). In other embodiments, the needle assembly 110 doesnot include the plunger 204. In such cases, a pressure generator (notshown) located within the positioning assembly 106 may be used to createa pressure within the lumen 217 of the coring needle 200, therebypushing the follicular unit 302 towards the patient as the punctureneedle 202 and the coring needle 200 is retracted. Such technique willcause the follicular unit 302 to dislodge from the coring needle 200while the coring needle 200 is being removed from the patient.

After the first follicular unit 302 has been implanted in the implantregion, the coring needle 200 is advanced distally until its distal end214 is distal to the distal end 234 of the puncture needle 202. Thecomputer 120 then operates the robotic arm 27 again to place the coringneedle 200 next to another target follicular unit 302 to be harvested.The above described process is then repeated to harvest the nextfollicular unit 302, and to implant the follicular unit 302. Theselection of the follicular unit 302 may be determined by the computer120. For example, in some embodiments, based on a location and geometryof the prescribed harvest region, the computer 120 selects a follicularunit 302 only if it is within the prescribed harvest region. In someembodiments, the above process is repeated until a prescribed number offollicular units 302 have been implanted in the implant region, until adensity of the implanted follicle units 302 reaches a prescribeddensity, or until there is no more available follicular unit 302 in theharvest region.

During the above harvesting and implanting process, the force sensor 100monitors one or more force/moment component transmitted from thepositioning assembly 106. For example, the force sensor 100 may monitora force Fz, which has a directional vector that is approximatelyparallel to an axis of the coring needle 200. The sensed force Fz istransmitted to the computer 120, which determines whether a magnitude ofthe sensed force Fz is within an acceptable limit. In some embodiments,the computer 120 is configured (e.g., programmed) to stop a harvestprocess or an implant process if the sensed force Fz exceeds aprescribed limit, which may indicate that the coring needle 200 or thepuncture needle 202 is pressing against the skull, for example. As such,the force sensor 100 provides a safety feature that prevents the coringneedle 200 and the puncture needle 202 from injuring a patient in anunintended way.

In other embodiments, instead of, or in addition to, using the forcesensor 100 as a safety feature, the force sensor 100 may also be used tocontrol a positioning of the coring needle 200 and/or the punctureneedle 202. As the coring needle 200 is being advanced through the skinand into tissue underneath the skin, the coring needle 200 experiences aforce Fz, which represents a resistance encountered by the coring needle200. FIG. 25 illustrates a force diagram that represents a forceresistance Fz sensed by the coring needle 200 as the coring needle isadvanced through the skin and into tissue. Such force Fz is transmittedby the various components within the positioning assembly 106 to theforce sensor 100, which measures such force Fz and transmits the forcedata to the computer 120. Because the skin surface is relatively tough,initially, as the coring needle 200 pushes against skin, it will notimmediately penetrates the skin, and will experience a force resistanceFz provided by the skin surface. The force resistance Fz increases fromzero to a value Fp, at which point, the coring needle 200 penetratesthrough the skin. Because the tissue underneath the skin is relativelysofter than the skin, the force resistance Fz experienced by the coringneedle 200 will be less than Fp after the coring needle 200 penetratesthe skin. As shown in FIG. 25, after the value Fp is reached, the forcecurve falls back to a second value Fs, which represents the forceresistance sensed by the coring needle 200 after it has penetrated theskin surface. The force Fz will continue to increase from that point asthe coring needle 200 continues to be advanced into the tissue. This isbecause as more portion of the coring needle 200 is advanced into thetissue, the coring needle 200 will contact more tissue that isunderneath the skin, thereby increasing an amount of surface frictionbetween the coring needle 200 and the tissue. In some cases, if thecoring needle 200 hits a bone, the force diagram will result in a spike(shown in dotted line in the figure).

The computer 120 may be programmed to monitor the force curve beinggenerated as the coring needle 200 is being advanced during the harvestprocess, and controls the coring needle 200 based on the force curve.For example, in some embodiments, the computer 120 activates apositioner in the positioning assembly 106 to advance the coring needle200 at a first rate until a dip in the force curve is observed,indicating that the coring needle 200 has penetrated the skin. Afterthat, the computer 120 then activates the positioner to advance thecoring needle 200 at a second rate until a desired penetration depth isaccomplished. In some embodiments, the first rate may be faster than thesecond rate.

In the above embodiments, the same coring needle 200 is used to harvestand implant multiple follicular units 302. In other embodiments,multiple coring needles may be provided, wherein each of the coringneedles may be used to harvest and implant one or more follicular units302. FIG. 26 illustrates a needle cartridge 400 in accordance with someembodiments. The cartridge 400 has a plurality of slots or openings 402,each of which sized to accommodate a coring needle 404. Each of thecoring needles 404 has a proximal end 406, a distal end 408, and a lumen410 extending between the proximal and the distal ends 406, 408. Thecoring needle 404 has a similar configuration as the coring needle 200described with reference to FIG. 21A. The slots 402 are locatedcircumferentially near a periphery of the cartridge 400. Alternatively,the slots 402 may be arranged in a different configuration. For example,in other embodiments, the slots 402 may be arranged in a form of amatrix having N number of rows by M number of columns. In theillustrated embodiments, the cartridge 400 further has a bottom 420,which may be adapted for placement on a surface (e.g., the surface 36shown in FIG. 1). The cartridge 400 also includes an engagement portion422 configured (e.g., sized and shaped) for detachably securing to acomponent of the positioning assembly 106. The engagement portion 422may be a slot/opening, a surface having a protrusion, or a connectordevice.

FIG. 27 illustrates a puncture needle holder 450 for holding a punctureneedle assembly 453 in accordance with some embodiments. The punctureneedle holder 450 may be used with the cartridge 400. The punctureneedle holder 450 includes a body 451 having an opening 452 foraccommodating the puncture needle assembly 453. The puncture needleassembly 453 may be fixedly secured to the puncture needle holder 450,or alternatively, be slidably coupled to the puncture needle holder 450.The puncture needle assembly 453 includes a puncture needle 454 having aproximal end 456, a distal end 458, and a lumen 460 extending betweenthe proximal and distal ends 456, 458. The puncture needle assembly 453also includes an engagement portion 462 secured to the proximal end 456of the puncture needle 454. The puncture needle 454 has a similarconfiguration as the puncture needle 202 described with reference toFIG. 21A. As shown in FIG. 27, a stand 470 may be provided to supportthe puncture needle holder 450.

FIG. 28 illustrates a positioning assembly 106 in accordance with otherembodiments. The positioning assembly 106 includes a cartridge holer500, a positioner 502 for positioning the cartridge holder 500, a coringneedle holder 504, and a positioner 506 for positioning the coringneedle holder 504. In other embodiments, the positioning assembly 106does not include the positioner 502, in which case, the cartridge holder500 does not move relative to the positioning assembly 106 after thecartridge holder 500 is detachably coupled to the cartridge holder 500.

FIGS. 29A-29D illustrate a method of using the positioning assembly 106of FIG. 28, the cartridge 400 of FIG. 26, and the puncture needle holder250 of FIG. 27 to harvest and implant a follicular unit in accordancewith some embodiments. First, the cartridge 400, with a plurality ofcoring needles 404 loaded therein, is placed on the support surface 36next to the positioning assembly 106. The camera(s) 28 is then used toview the cartridge 400 and transmit image data to the computer 120 forprocessing. The computer 120 processes the image data to determine aposition of the cartridge 400, and activates the robotic arm 27 to pickup the cartridge 400 based on the processing of the image data (FIG.29A). In some embodiments, the computer 120 is configured to recognize afeature associated with the cartridge 400. For example, the cartridge400 may have a marker attached thereto, in which case, the computer 120is configured to determine the marker location. Various techniques maybe employed to allow the robotic arm 27 to pick up the cartridge 400. Inthe illustrated embodiments, the cartridge holder 500 of the holderassembly 106 is shaped and sized to detachably mate with the engagementportion 422 of the cartridge 400. For example, if the engagement portion422 comprises a slot, the cartridge holder 500 may be implemented as asnap-on extension that is configured to be inserted into the slot. Inother embodiments, the cartridge holder 500 may include anelectromagnetic device that generates a magnetic field using a current.In such cases, the engagement portion 422 of the cartridge 400 includesa magnet that can be coupled to the cartridge holder 500.

Next, the positioner 506 is activated to move the coring needle holder504 so that the coring needle holder 504 engages with one of the coringneedles 404. The coring needle holder 504 picks up the coring needle404, and is moved to an operative position in the positioning assembly106 at which the coring needle 404 may be positioned (e.g., rotatedand/or advanced) for coring a follicular unit (FIG. 29B). The roboticarm 27 is then activated to move positioning assembly 106 such that thecoring needle 404 at the operative position is adjacent to a targetfollicular unit, and the coring needle 404 is used to core the targetfollicular unit (e.g., by rotating the coring needle 404 using a motor(not shown), or by advancing and retracting the coring needle 404 in athrusting action). The technique for coring the follicular unit issimilar to that discussed previously. After a first follicular unit hasbeen cored, the positioner 506 is activated to move the coring needleholder 504 to place the coring needle 404 back to the slot 402 of thecartridge 400. The positioner 506 then moves the coring needle holder504 to pick up another empty coring needle 404 from another slot 402,and the process is repeated until all of the coring needles 404 havebeen used to harvest respective follicular units, or until a desirednumber of follicular units have been obtained.

In some embodiments, if the cartridge holder 500 is rotatable about itsaxis, the cartridge holder 500 may be rotated to place a coring needle404 at a location from which the coring needle holder 504 may pick upand place back the coring needle 404.

When a desired number of follicular units have been obtained, therobotic arm 27 is positioned to pick up the puncture needle holder 450(FIG. 29C). In the illustrated embodiments, the puncture needle holder450 is supported on the stand 470, which is placed on the supportsurface 36. Similar technique for picking up the cartridge 400 may beemployed to pick up the puncture needle holder 450. For example, thecamera(s) 28 and the computer 120 may be used to determine a position ofthe puncture needle holder 450, and the puncture needle holder 450 maybe have an engagement portion (not shown) configured for detachablycoupled to a component (not shown) of the positioning assembly 106.

After the puncture needle holder 450 has been picked up by thepositioning assembly 106, the robotic arm 27 is activated to move thepositioning assembly 106 such that the coring needle 454 is adjacent toa target implant location. The positioner 506 then moves the coringneedle holder 504 to pick up one of the coring needles 404 (whichcontains a harvested follicular unit), and moves the coring needle 404such that it is at least partially within the lumen 460 of the punctureneedle 454 (FIG. 29D). The coring needle 404 and the puncture needle 454are then used to implant the follicular unit in the coring needle 404using similar technique as that described previously. After thefollicular unit has been implanted, the positioner 506 moves the coringneedle holder 504 to place the empty coring needle 404 back to thecartridge 400, and the coring needle holder 504 picks up another coringneedle 404 that has a harvested follicular unit. The above process isrepeated to implant one or more additional follicular unit(s) at theimplant region.

When all of the follicular units in the loaded coring needles 404 havebeen implanted in the implant region, if additional implanting isdesired, the positioning assembly 106 places the puncture needle holder450 back to its original location (e.g., on the stand 470), anddecouples the puncture needle holder 450 from the positioning assembly106. The cartridge 400 and the coring needles 404 are then used again toharvest additional follicular unit(s) from the harvest region, using thesame process as that described.

FIG. 30 illustrates a skin tensioner 500 that may be used withembodiments described herein. The skin tensioner 500 includes a shaft501, a horizontal support 502, and two side tines 503. Each tine 503includes a distal portion 504 for pressing against a skin surface. Theproximal end 506 of the shaft 501 is configured (e.g., sized and shaped)to engage with an end-effector of the robotic hair transplant system.The horizontal support 502 includes a spring-loaded mechanism (notshown) that exerts a force along the x-axis, thereby causing the tines503 to spread apart from each other. During use, the distal portions 504of the tines 503 are positioned next to a follicular unit, with thefollicular unit being between the two distal portions 504. Thespring-loaded mechanism then spreads the tines 503 apart to therebytension the skin. As a result, the hair shaft associated with thefollicular unit may stand more erect relative to the scalp surface. Insome cases, the skin tension may also serve to temporarily occludevessels (e.g., capillaries) surrounding the follicular unit, therebyreducing bleeding during the harvesting of the follicular unit. Thepuncture needle and coring needle described herein would act between thedistal portions 504 of the tines 503.

In embodiments of the invention, the attending physician or operator canspecify where a follicular unit needs to be implanted and at what angle,i.e., its relative location (or “implantation site”), orientation, anddepth. This specification of the location, orientation and/or depth of ahair follicle to be implanted may be carried out by a treatment planningsystem. Alternatively, during the implanting mode, when the camera(s)are viewing the recipient area of the scalp, the attending operator mayuse a user interface (e.g., a conventional computer mouse) to specifythe implant location and/or position and/or orientation and/or implantdepth. Alternatively, the operator can point to location on the scalp byplacing a temporary fiducial, such as an ink mark or a pointer that canbe visualized, identified, and measured by the image processing system.Further, orientation can be specified directly on the computer monitoras a combination of two angles, such as rotation about x-axis and arotation about y-axis (assuming that z-axis is along the needle), or byplacing an elongated pointer on the scalp, which the image processingsystem can visualize and measure the angles.

In any case, the control of the robotic arm now becomes two steps.First, based on the specification of the location and orientation of theimplant location, the computer processor directs the robot to move theimplant needle to the desired location and orientation. Second, theactual implantation takes place, either solely by actuating themechanism, or by a combination of robotic movement and/or mechanismactuation, in which the desired implant depth is achieved. Another wayof specifying the orientation of the implanted follicular unit is tohave the system match to the orientation of the existing hairs in thearea of the implant. The system, after moving the implantation needle tothe implant location, visualizes and measures the orientation of thehair follicles in the neighborhood of the implant location, and usesthat orientation as the specification for the implant. In the case ofneighboring hairs having different orientations, the system may, forexample, obtain a weighted average of the various orientations forimplanting the follicular unit.

FIG. 31 illustrates an implant needle 550 in accordance with yet anotherembodiment, and which also may be used with other embodiments describedherein. The implant needle 550 is configured to harvest and divide afollicular unit into a plurality of follicular sections (i.e., slices).It is believed that each of the follicular sections obtained from thesingle follicular unit using the needle 500 has the ability toregenerate into a new follicular unit when replanted in the patient'sscalp, so long as the respective follicular section contains asufficient quantity of follicular epithelial stem cells and thestructural matrix of the collagenous sheath. For more information,reference is made to Jung-Chul Kim and Yung-Chul Choi, “Hair Survival ofPartial Follicles: Implications for Pluripotent Stem Cells andMelanocyte Reservoir,” which is published as Chapter 9C in the textbook“Hair Transplantation, Fourth Edition, Revised and Expanded by Walter P.Unger and Ronald Shapiro (Marcel Dekker, Inc. 2004) and which is fullyincorporated herein by reference.

The implant needle 550 includes a lumen 554 and three slots 552 a-552 ctransverse to an axis of the implant needle 550. The proximal end (notshown) of the implant needle 550 may be coupled to a needle assembly ora positioner, as described herein. During use, the implant needle 550 isused to core and harvest a follicular unit 560 (FIG. 32A). After thefollicular unit 560 has been harvested, cutting elements 564 a-564 c arethen inserted into respective slots 552 a-552 c, thereby cutting thefollicular unit 560 into a plurality of sections 562 a-562 d (FIG. 32B).Notably, slots 552 a-552 d are located so that the cuts are made atmid-section of the follicular unit, where the follicular epithelial stemcells are concentrated. Each cutting element 564 a-c may be a platehaving a sharp edge, or may have another configuration. In theillustrated embodiments, each cutting element 564 a-c may include achannel 566 for delivering a fluid (e.g., culture nutrient) between thefollicular sections 562.

After the follicular sections 562 have been created, the cuttingelements 564 are then retracted. As the cutting elements 564 are beingretracted, fluid containing culture nutrient may be delivered throughchannels 566 of respective cutting elements 564. After the cuttingelements 564 have been completely removed from the lumen 554 of theimplant needle 550, a tube 570 may be placed around the implant needle550 to thereby prevent the fluid between the follicular sections 562from escaping through the slots 552 (FIG. 32C). In some embodiments, thefluid may be a quick setting material, such as paraffin or a gel, whichacts to encapsulate (i.e., protect) and stabilize the follicularsections, and helps ensure they are implanted in the scalp in the sameorientation as in the donor follicle.

In some embodiments, the insertion of the cutting elements 564 into thelumen 554 may be performed simultaneously. In other embodiments, thebottom-most cutting element 564 c may be inserted first, thereby pushingthe remaining follicular unit 560 upward. Then the next bottom-mostcutting element 564 b is inserted, thereby pushing the remainingfollicular unit 560 upward. The last cutting element 564 a is theninserted. In other embodiments, instead of having three slots 552 a-552c, the implant needle 550 may have more or less then three slots 552. Insuch cases, the number of cutting elements 564 would correspond with thenumber of slots 552 on the implant needle.

In some embodiments, a plunger (e.g., plunger 204) may be used toimplant the follicular sections 562 at different target locations. Forexample, the plunger 204 may be advanced to push the follicular sections562 a-562 d distally until the distal most follicular section 562 d isoutside the lumen 554 of the implant needle 550. The implant needle 550is then moved to a different target location, and the plunger 204 isfurther advanced to push the next follicular section 562 c out of thelumen 554. The process is repeated until all of the follicular sections562 a-562 d have been implanted. In other embodiments, the distal mostfollicular section 562 d (the follicular base) is discarded and is notused. In further embodiments, the proximal most follicular section 562 a(the follicular top) is discarded and is not used.

The forgoing illustrated and described embodiments of the invention aresusceptible to various modifications and alternative forms, and itshould be understood that the invention generally, as well as thespecific embodiments described herein, are not limited to the particularforms or methods disclosed, but to the contrary cover all modifications,equivalents and alternatives falling within the scope of the appendedclaims. By way of non-limiting example, it will be appreciated by thoseskilled in the art that the invention is not limited to the use of arobotic system, including a robotic arm, and that other automated andsemi-automated systems that have a moveable arm assembly may be used forcarrying and precisely positioning the respective camera(s) andharvesting/implanting needle assemblies adjacent the body surface.

What is claimed:
 1. An apparatus for creating a plan for hairtransplantation, the apparatus comprising: a user interface; and aprocessor configured to execute instructions for: identifying existinghair in an image of a body surface; creating a hair transplantationtreatment plan including one or more parameters; and generating aproposed curve having hair implantation locations and hair orientations,the hair implantation locations of the proposed curve and the hairorientations of the proposed curve automatically generated based onspecified control points and orientations at the specified controlpoints, wherein the hair implantation locations and hair orientationsare automatically planned taking into consideration and avoiding theexisting hair.
 2. The apparatus of claim 1, wherein the instructionscomprise instructions for identifying one or more global landmarks inthe image of the body surface and wherein the hair implantationlocations and hair orientations are automatically planned with respectto the one or more global landmarks.
 3. The apparatus of claim 2,wherein the apparatus is configured for use in association with anautomated system for hair transplantation and the apparatus is furtherconfigured to guide movements of the automated system for hairtransplantation based on the one or more global landmarks and thecreated plan for hair transplantation.
 4. The apparatus of claim 1,wherein the instructions comprise instructions for selecting a hairgraft from a harvest region and repeat a selection process until: 1) aprescribed number of hair grafts has been reached; 2) a prescribeddensity has been reached, or 3) until there are no more available hairgrafts in the harvest region.
 5. The apparatus of claim 1, wherein theuser interface is configured to allow a user to input at least one ofthe one or more parameters of the treatment plan.
 6. The apparatus ofclaim 1, wherein the one or more parameters comprises a number of hairfollicles to be removed/implanted, a location of a harvest region, alocation of an implant region, a degree of randomness associated withimplant locations, a spacing between adjacent implant locations, a depthof implant, a patient identification, a geometric profile of a harvestregion, a geometric profile of an implant region, marker location(s), ora density of implant locations.
 7. The apparatus of claim 1, wherein theone or more parameters of the treatment plan may be determined in realtime.
 8. The apparatus of claim 1, wherein the processor is configuredto receive and process images acquired by an image acquisition device.9. The apparatus of claim 1, wherein the hair implantation locations andorientations are generated from the control points using interpolationtechniques.
 10. The apparatus of claim 9, wherein the interpolationtechnique comprises a cubic b-spline.
 11. The apparatus of claim 1,wherein the hair implantation locations are randomized, and an amount ofrandomization is user-specified or processor-generated.
 12. Theapparatus of claim 1, wherein the processor is configured to create theimplantation locations in a natural-looking pattern.
 13. The apparatusof claim 1, wherein the user interface comprises a display.
 14. Theapparatus of claim 1, wherein the processor is configured to registerthe treatment plan with a patient.
 15. The apparatus of claim 14,wherein the instructions comprise instructions for identifying alocation of a harvest region on the patient and a target hair in theharvest region.
 16. An apparatus for creating a plan for hairtransplantation, the apparatus comprising: a user interface; and aprocessor configured to execute instructions for: identifying existinghair in an image of a body surface; and creating a hair transplantationtreatment plan including a harvesting region and an implantation region,wherein the implantation region comprises proposed hair implantationlocations and hair orientations at the proposed hair implantationlocations; wherein the instructions comprise instructions foridentifying one or more global landmarks in the image of the bodysurface, and wherein the hair implantation locations and hairorientations are automatically planned with respect to the one or moreglobal landmarks taking into consideration and avoiding existing hair.17. The apparatus of claim 16, wherein the processor is furtherconfigured to determine one or more parameters of the hairtransplantation treatment plan in real time as hair transplantationprocedure is being performed based on the analysis of the images of theprocedure taken by an image acquisition device.
 18. A method forcreating a plan for hair transplantation, the method comprising:processing, by a processor, an image of a body surface to identifyexisting hair; and creating a hair transplantation treatment planincluding one or more parameters, wherein the creating step comprisesgenerating a proposed curve having hair implantation locations and hairorientations, the hair implantation locations of the proposed curve andthe hair orientations of the proposed curve automatically generatedbased on specified control points and orientations at the specifiedcontrol points; and wherein the hair implantation locations and hairorientations are automatically planned taking into consideration andavoiding the existing hair.
 19. The method of claim 18, furthercomprising identifying one or more global landmarks in the image of thebody surface and automatically planning the hair implantation locationsand the hair orientations with respect to the one or more globallandmarks.
 20. The method of claim 19, wherein the method is used inassociation with an automated system for hair transplantation and themethod further comprises guiding movements of the automated system forhair transplantation based on the one or more global landmarks and thecreated plan for hair transplantation.
 21. The method of claim 20,wherein the method further comprises using an air jet to direct an airstream at a body surface during hair transplantation procedure.
 22. Themethod of claim 18, comprising selecting a hair graft from a harvestregion and repeating a selection process until: 1) a prescribed numberof hair grafts has been reached; 2) a prescribed density has beenreached, or 3) until there are no more available hair grafts in theharvest region.
 23. The method of claim 18, comprising allowing a userto input or modify at least one of the one or more parameters of thetreatment plan.
 24. The method of claim 23, wherein the one or moreparameters may be input or modified in real time.
 25. The method ofclaim 18, wherein the hair implantation locations are randomized, and anamount of randomization is user-specified or processor-generated. 26.The method of claim 18, further comprising registering the treatmentplan with a patient.